Identity
- Trade Name
- Midway Select FDA UDI
- Generic Name
- Endodontic filling/sealing material FDA UDI
- Device Name
- Gutta Percha Points, Taper .06, Size #15, 60pcs/box FDA UDI
- Model / Reference
- 002-0558 FDA UDI
- Description
- Gutta Percha Points, Taper .06, Size #15, 60pcs/box FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10843717107238 FDA UDI
- FDA Product Code
- EKM FDA UDI
- GMDN Term
- Endodontic filling/sealing material FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endodontic filling/sealing material
Midway Select by Midway Dental Supply, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Hygenic — Coltene/Whaledent Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Midway Dental Supply, Llc
Sources (1)
- FDA UDI eb7cf222-8a0e-4e8a-be70-cfcb0211a08a 33 fields · synced Jun 1, 2026